Job Description


* This role will be the lead business analyst on a large global project to implement a validated Regulatory Information Management (RIM) suite SaaS vendor solution and necessary system integrations to existing Baxter systems, as well as migrate legacy data into the new RIM solution.

* The ideal candidate will have the following experience:
o Implemented a new validated SaaS software vendor solution from beginning to end, including system integrations
o Led the work effort of other business analysts on a large project
o Managed the creation and approval of the deliverables in a validation package
o Analyzed legacy data; analyzed legacy and new data models; designed data mapping from legacy system to new system; migrated legacy data into new system
o Designed the data flow through a new software solution, including upstream and downstream interfaces
o Redesigned business processes to match the new software solutionu2019s functionality and data flow
o Led requirements gathering across many global functional teams for a new software solution
o Designed and led the validated testing effort for a new software solution
o Collaborated with a software vendor (i.e., understanding the capabilities of the software vendor solution and identifying gaps/mitigations, resolving test defects, etc.)
o Regulatory Affairs, Regulatory Information Management

Critical Responsibilities

Business Enabling and Envisioning
* Engage and communicate effectively with business leaders and business subject matter experts to define and align on constructive and tangible strategies
* Collaborate with business partners to influence core technology selection and standards across a diverse range of business-critical R&D solutions
* Partner with business partners, vendors and peers as part of shaping and delivering the overall solutions.
* Best in class vendor selection and management, including niche vendor strategies as needed
* Collaborate with business partners to estimate and quantify the impact and business value of key initiatives
* Plan and execute global requirements gathering through workshops/product demonstrations at both global and regional level whilst maintaining traceability and compliance at the core.
* Deliver presentations; facilitate and address issues at all levels of management.

Business Analysis
* Lead and set direction for business functional requirements, technical requirements and solution delivery on enterprise/large projects within Baxteru2019s R&D IT function.
* Gather, understand and document business objectives, requirements, functional specifications through workshops/interviews/meetings.
* Manage the creation and approval of the deliverables in a validation package
* Identify, evaluate, develop and /or redesign systems and procedures that meet user requirements.
* Define, design and document business flows and processes for large, highly complex projects. Understand interdependencies of systems for multiple businesses or functions. Provide cross-functional and business knowledge to develop business system and process alternatives.
* Design data flow through software solutions, including upstream and downstream interfaces
* Use technical tools (queries, process maps, etc.) for problem resolution.
* Conduct data analysis; design business rules for data accuracy and consistency; design data mapping and data migration. Identify and resolve data quality issues.
* Establish validation test strategy; develop and execute test cases; lead validation testing with IT and business partners; manage defects with software vendors and IT.
* Assist in development of training materials and/or conduct training.
* Provide support on R&D business applications.
* Understand and follow appropriate SDLC, quality validation processes and application processes.
* Communicate status, solutions and concerns.
* Disseminate information in a timely manner within the team and across functions.
* Make decisions that have a cross-functional or business impact and analyze financial impact.

People/Project Management
* Provide input to project manager on project charters, project plans,project estimates/budgets and status reports.
* Manage work effort for self and less experienced business analysts assigned to your project.
* Mentor less experienced business analysts.
* Train others on specific area of business or systems expertise.

Vendor Management
* Collaborate with software vendors (i.e., understand capabilities of software vendor solution and identify gaps/mitigations, resolve issues, etc.)

Key Qualifications

* Bachelor's degree in Information Technology
* 15+ years of business analysis experience and implementing IT solutions
* Prefer 3+ years of regulatory affairs and/or regulatory information management experience
* Demonstrate strong business acumen, solution delivery expertise and a strong understanding of systems for both on-premise and SaaS offerings
* Proven success (3+ years) managing large project requirements highly desired
* Ability to accomplish results through others, utilizing effective influencing and leadership skills
* Must be able to solve complex business problems and present recommendations to senior management effectively
* Must be able to define, shape, and drive projects to completion while effectively collaborating with others
* Experience working on all SDLC business processes: requirements, design, development, testing, training and deployment
* Experience working with third-party external teams in the support and implementation of IT solutions
* Data analysis and data migration experience
* Require limited direction; give significant direction; detail and quality oriented; possess extensive knowledge of policies, standards and procedures; have excellent presentation, communication, teamwork and interpersonal skills

Apply Now

Job Location

Apply Now